DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/16/2026 has been entered.
Response to Amendment
This Office action is in response to the applicant’s communication filed 07/16/2026.
Status of the claims:
Claims 1 – 11, 13, and 18 – 25 are pending in the application.
Claims 18 – 25 are new.
Claims 22 – 25 are withdrawn.
Claims 1, 3, 8, 9, 11, and 13 are amended.
Election/Restrictions
Newly submitted claims 22 – 25 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
The invention of claims 1 – 11, 13, and 18 – 21 (i.e., the originally claimed invention) and the invention of claims 22 – 25 are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case the product as claimed can be used in a materially different process such as breaking/cutting and removing tissue or removing/implanting a non-helical wire rope implant into/from the body.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
the inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries); the prior art, applicable to one invention would not likely be applicable to another invention.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 22 – 25 have been withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Drawings
The drawings were received on 07/16/2026. These drawings are accepted.
The replacement drawings for Figs. 9A – 10C were received on 07/16/2026. These drawings are acceptable and overcome the previous drawing objections in the Final office action mailed on 04/24/2026.
Claim Objections
The objections to claims 1, 3, and 13 in the previous action dated 04/24/2026 have been withdrawn in light of the Applicant’s amendments filed 07/16/2026. Specifically, the objections to claim 1 regarding the phrases “a helicl wire rope structure electrode”, “it”, and “which is mechanically engage to”, the objection to claims 1 and 3 regarding the phrase “said a helical wire rope structure electrode” and/or “a helical wire rope structure electrode”, and the objection to claim 13 regarding the phrase “a rotational driver” have all been withdrawn as the appropriate corrections have been made. However, new objections have been set forth below in light of Applicant’s amendments.
Claims 19 and 21 are objected to because of the following informalities:
Claims 19 and 21 recites “the helical wire rope structure electrode” in lines 10 and 4, respectively, although the lines are understood by the Examiner to mean “the wire rope structure electrode”, as previously defined in the preamble and repeated within claim 19, the Examiner suggests each instance of “the helical wire rope structure electrode” be amended to recite “the helical wire rope structure electrode” or each instance of “the wire rope structure electrode” be amended to read “the helical wire rope structure electrode” for the purpose of maintaining consistent language throughout the claims;
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
The rejection of claim 3 under U.S.C 35 112(b) for failing to comply with the written description requirement, recited in the previous action dated 04/24/2026 have been withdrawn in light of the Applicant’s amendments filed 07/16/2026. Specifically, the rejection of claim 3, regarding the phrase "the system includes at least one tool selected from the group consisting of a hooking slot, a hook and corkscrew" rendering the claim unclear if Applicant is adding additional structure to the system or further defining the previously claimed structure, has been withdrawn as the phrase amended to make clear the limitation is intended to further define the previously claimed structure.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 – 5, 7, 10, 11, and 19 are rejected under 35 U.S.C. 102(a)(1)/(2) as being anticipated by Begg (US 2021/0322047 A1) (filed on April 17th 2020).
Regarding claim 1, Begg discloses a system (tissue resecting device 10) (abstract, paragraphs [0017 – 0030] and Figs. 1 – 4) capable of removing a helical wire rope structure electrode from bodily tissue (Examiner’s note: it should be understood that a preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67,190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d150,152,88; with that being said, because the system of Begg is used for grasping and removing tissue as discussed in the abstract, the Examiner contends the system is therefore capable of functioning to grasp / remove a helical wire rope structure electrode from bodily tissue), the system comprising:
a handle (housing 110) housing a rotational driver (drive assembly 220) that provides rotational motion relative to said handle (paragraphs [0022 – 0024] and Figs. 1 – 4);
a removal needle (end-effector assembly 110) comprising a shaft (inner shaft 130) operationally engaged with said rotational driver (paragraph [0018] and Fig. 1), a tip (tool portion 125) and an attachment tool (cork-screw member 152) associated with said tip (tool portion 125) (paragraphs [0032 – 0033] and Figs. 2 – 4),
the tip (tool portion 125) configured to remove said helical wire rope structure electrode and said attachment tool (cork-screw member 152) being configured to mechanically engage the helical wire rope structure electrode to allow the helical wire rope structure electrode to be unzipped from the from surrounding structures by applying a torque using said rotational driver to remove said helical wire rope structure electrode and then using said removal needle to withdraw the helical wire rope structure electrode intact by withdrawing said removal needle which is mechanically engaged to said unzipped helical wire rope structure electrode (Examiner’s note: it should be understood that the preceding limitations are intended use limitations which require only that the structure of the prior art be capable of functioning in the manner claimed. With that said, the cork-screw member 152 (i.e., the attachment tool) is rotatable / rotated distally via the drive assembly 220 (i.e., the driver) such that the barb 154a of the tool portion 125 (i.e., the tip) engages with tissue and then the cork-screw member 152 (i.e., the attachment tool) is rotatable / rotated proximally via the drive assembly 220 (i.e., the driver) such that the tissue is pulled within the end effector assembly 100 (i.e., the removal needle); therefore, the Examiner contends that the same process above can be applied to a helical wire rope structure electrode with the structure of Begg and, thus, the structure of the prior art is capable of functioning in the manner claimed).
Regarding claim 2, Begg discloses wherein the removal needle (end-effector assembly 110) further comprises an interior channel (lumen of shaft 120) and said attachment tool (cork-screw member 152) is configured to pull the helical wire rope structure electrode through said interior channel when said helical wire rope structure electrode is unzipped from the surrounding tissue (Examiner’s note: it should be understood that the preceding limitations are intended use limitations which require only that the structure of the prior art be capable of functioning in the manner claimed. With that said, the cork-screw member 152 (i.e., the attachment tool) is rotatable / rotated proximally via the drive assembly 220 (i.e., the driver) such that the tissue is pulled within the lumen of the shaft 120 of the end effector assembly 100 (i.e., the removal needle); therefore, the Examiner contends that the same process above can be applied to a helical wire rope structure electrode with the structure of Begg and, thus, the structure of the prior art is capable of functioning in the manner claimed).
Regarding claim 3, Begg discloses wherein said attachment tool (cork-screw member 152) further comprises at least one tool selected from the group consisting of a hooking slot, a hook, and a corkscrew (cork-screw member 152).
Regarding claim 4, Begg discloses wherein said removal needle (end-effector assembly 110) further comprises a side port (window 128) connected to said interior channel near said tip of the removal needle (end-effector assembly 110) (paragraphs [0027 – 0028], [0032 – 0033], and Figs. 2 – 4).
Regarding claim 5, Begg discloses wherein said removal needle (end-effector assembly 110) is configured to be exposed to the helical wire rope structure electrode through said side port (window 128) (Examiner’s note: the window 128 is capable of being exposing the end-effector assembly 110 (i.e., the removal needle) to a helical wire rope structure electrode).
Regarding claim 7, Begg discloses wherein said tip (tool portion 125) of the removal needle (end-effector assembly 110) is blunt (Fig. 2).
Regarding claims 10 and 11, Begg discloses further comprising a connection port (outflow tubing 240) that allows connection to an external system (fluid management system “F”) configured to connect to a suction device (paragraphs [0016], [0022 – 0023], [0027], and Fig. 1).
Regarding claim 19, Begg discloses a system (tissue resecting device 10) (abstract, paragraphs [0017 – 0030] and Figs. 1 – 4) capable of removing a wire rope structure electrode from bodily tissue (Examiner’s note: it should be understood that a preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67,190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d150,152,88; with that being said, because the system of Begg is used for grasping and removing tissue as discussed in the abstract, the Examiner contends the system is therefore capable of functioning to grasp / remove a helical wire rope structure electrode from bodily tissue), the system comprising:
a handle (housing 110) housing a rotational driver (drive assembly 220) that provides rotational motion relative to said handle (paragraphs [0022 – 0024] and Figs. 1 – 4);
a removal needle (end-effector assembly 110) (paragraph [0018]) having,
a shaft (inner shaft 130) operationally engaged with the rotational driver (paragraph [0024]),
a tip (tool portion 125) (paragraph [0028] and Figs. 2 – 4); and
an attachment tool (cork-screw member 152) associated with said tip (paragraphs [0032 – 0033] and Figs. 2 – 4) and configured to mechanically engage the wire rope structure electrode to allow applying a torque to the helical wire rope structure electrode by using said rotational driver to rotate the shaft of said removal needle (Examiner’s note: it should be understood that the preceding limitations are intended use limitations which require only that the structure of the prior art be capable of functioning in the manner claimed. With that said, the cork-screw member 152 (i.e., the attachment tool) is rotatable / rotated distally via the drive assembly 220 (i.e., the driver) such that the barb 154a of the tool portion 125 (i.e., the tip) engages with tissue and then the cork-screw member 152 (i.e., the attachment tool) is rotatable / rotated proximally via the drive assembly 220 (i.e., the driver) such that the tissue is pulled within the end effector assembly 100 (i.e., the removal needle); therefore, the Examiner contends that the same process above can be applied to a helical wire rope structure electrode with the structure of Begg and, thus, the structure of the prior art is capable of functioning in the manner claimed).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Begg (US 2021/0322047 A1) as applied to claim 1 above, and further in view of Rebellino et al (US 2022/0071732 A1) (priority to provisional filed on May 30th 2019 which contains the same disclosure relied upon by the Examiner below).
Regarding claim 6, as discussed above, Begg discloses the system of claim 1 above.
However, Begg is silent regarding (i) wherein the tip of the removal needle is sharp and configured to penetrate the bodily tissue.
As to the above, Rebellino teaches a system (delivery device 750) comprising needle (outer cannula 762; which equates to the outer shaft 120 of the end-effector assembly of Begg) with a sharp distal tip (sharp tip 766; which equates to the tip of tool portion 125 of Begg) for the purpose of allowing the system to penetrate the tissue without needing assistance from another device (paragraph [0100]).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the tip of the tip (tool portion 125) of Begg to incorporate a sharp tip, based on the teaches of Rebellino, for the purpose of allowing the system to penetrate the tissue without the need assistance from another device (paragraph [0100] – Rebillino).
Claims 8, 9, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Begg (US 2021/0322047 A1) as applied to claims 1 and 19 above, and further in view of Maguire et al (US 2016/0361088 A1).
Regarding claims 8, 9, and 20, as discussed above, Begg discloses the system of claims 1 and 19 above.
However, Begg is silent regarding [claims 8 and 20] (i) an introducer tool comprising a penetrating tip and an introducer channel sized to allow insertion of said removal needle through said introducer channel and through which said removal needle passes, (ii) said removal needle mechanically engageable with said helical wire rope structure electrode being movable with respect to said introducer tool in at least one operating condition of the system, and [claim 9] (iii) an introducer tool engagement rod that selectively connects said introducer tool to said handle.
As to the above, Maguire teaches a system (system 100) comprising a handle (handle assembly 170) operably connected to a needle (stylet 135 with a sharp end 145; which equates to the end effector system 110 of Begg) and an introducer tool (distal end 120 of cannula 105) comprising a penetrating tip (distal end 120) (abstract, paragraph [0055], [0061 – 0062], and Fig. 1) and an introducer channel (channel through distal end 120) through which the needle (stylet 135 with a sharp end 145) passes, and an introducer tool engagement rod (cannula shaft 105 and hub 125) selectively connectable to the handle (handle assembly) (paragraphs [0061 – 0062]).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the system of Begg to incorporate a selectively couplable introducer tool with a sharp tip, through which the removal needle can move, based on the teachings of Maguire, for the purpose of providing access to the internal body tissue (e.g., by piercing a luminal wall) and to provide a conduit through which one or more devices (e.g., the end-effector assembly 110 of Begg) may pass to facilitate the subsequent treatment of the body lumen / tissue (paragraph [0052] – Maguire).
Claims 13, 18, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Begg (US 2021/0322047 A1) as applied to claims 1 and 19 above, and further in view of Shelton, IV et al (US 2020/0405403 A1).
Regarding claims 13, 18, and 21, as discussed above, Begg discloses the system of claims 1 and 19 above.
However, Begg is silent regarding (i) at least one force-conditioning device operably connected between said rotational driver and said attachment tool to condition applied force when removing the helical wire rope structure electrode, said at least one force-conditioning device including at least one device selected from the group of a force limiting fuse and a force smoothing device connected to said removal needle or incorporated into said removal needle.
As to the above, Shelton, IV teaches a surgical system comprising a rotational driver (motor pack 40050) for rotationally driving a surgical instrument 40200 (which equates to the attachment tool – helical coil 152 – of Begg) and a force-conditioning device / force limiting fuse (torque fuse) operably connected between the rotational driver (motor pack 40050) and the surgical instrument 40200 for limiting the maximum force exertable from the rotational driver (motor pack 40050) onto the surgical instrument (paragraph [0761]).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the rotational driver of Begg to incorporate at least one force conditioning device / at least one force limiting fuse, based on the teachings of Shelton, IV, wherein the at least one force conditioning device / force limiting fuse is connected to removal needle (i.e., the end-effector assembly 110) for the purpose of limiting the force exertable from the rotational driver onto the attachment tool (i.e., the helical coil 152) and preventing excess or undue damage to any tissue in the surrounding area or the tissue that has been grasped (paragraph [0761] – Shelton, IV).
Response to Arguments
Applicant’s arguments, filed 07/16/2026, with respect to the rejection of claims 1 – 11 and 13 under Mohajer, Norton, and/or Levine have been considered but are moot as the arguments are directed to Applicant’s amendments, and the previous rejection of the claims has been withdrawn in light of said amendments. Specifically, the rejections were withdrawn because Mohajer, Norton, and Levine do not teach a rotational driver that provides rotation relative to the handle. It is noted that a new rejection has been made over Begg, wherein Begg is relied upon for teaching the newly added limitations as discussed above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Andrew Restaino whose telephone number is (571)272-4748. The examiner can normally be reached Mon - Fri 8:00 - 4:00 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Andrew Restaino/Primary Examiner, Art Unit 3771
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